Pharmalucence, Inc. recalls Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC
Pharmalucence recalls 5-count and 30-count boxes of Technetium Tc99m Medronate kits due to reported sterility breach. This could lead to infections if used improperly.
Recall notice
Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.
Contact the company & request your remedy
What happened, in plain English
Pharmalucence is recalling kits for preparing Technetium Tc99m Medronate used in medical imaging. The kits have a reported breach in sterility, which could cause infections if used. Read more at govinfonow.com/recall/40498-pharmalucence-technetium-tc99m-medronate-kit-recall-sterility-breach-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40498-pharmalucence-technetium-tc99m-medronate-kit-recall-sterility-breach-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-1040-2018
Cite this page
“Pharmalucence Technetium Tc99m Medronate Kit Recall: Sterility Breach Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40498-pharmalucence-technetium-tc99m-medronate-kit-recall-sterility-breach-risk. Based on FDA recall #D-1040-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1040-2018%22&limit=1).
Why it’s dangerous
The kits have a reported breach in sterility, meaning they might not be sterile when used. This could lead to infections in patients during medical imaging procedures if the kits are not handled correctly.
Who’s affected
Healthcare professionals who use these kits for medical imaging procedures are affected. Patients receiving the imaging tests could be at risk of infection if the kits are used without proper sterility.
How to tell if you have this one
Check for the 5-count box (NDC 45567-0040-1) or 30-count box (NDC 45567-0040-2) with lot number 4223. These kits are prescription-only and manufactured by Pharmalucence, Inc.
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Pharmalucence- Category
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What to do — step by step
Check Kit Details
Verify the product's NDC code and lot number to confirm if it's recalled.
Questions people ask
Is this product safe to use?
The recall states there is a reported breach of sterility, so it is not safe to use without the remedy.
What should I do if I have this product?
The recall does not specify a remedy, so contact Pharmalucence for guidance.
How can I check if my kit is recalled?
Look for the NDC codes 45567-0040-1 (5-count box) or 45567-0040-2 (30-count box) with lot number 4223.
Contact Pharmalucence
We’ve drafted a message you can send Pharmalucence to request your refund or repair — edit it as you like.
Subject: Recall D-1040-2018 — Pharmalucence Pharmalucence Hello, I own a Pharmalucence that is covered by recall D-1040-2018 from Pharmalucence. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1040-2018 (June 6, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1040-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.